Orofacial clefts are among the most common congenital anomalies with prevalence of about one out of every seven hundred births in the United States. Throughout their lives, children who have an orofacial cleft need several surgical procedures and complex medical treatments requiring various medical and dental specialists.
Studies support the use of pre-surgical infant orthopedic treatment, such as a Nasoalveolar Molding (NAM) appliance, to create a more aesthetic result after primary lip closure in patients with cleft lip and palate deformities. Studies have also shown improved nasal symmetry with the use of a nasal molding appliance following primary closure of the lip. In the neonate, temporary plasticity of the alar cartilages exists due to higher levels of hyaluronic acid circulating in the infant which allows for orthopedic changes. NAM appliance works to stretch and contour the alar tissue and the columella while bringing the palatal shelves into closer approximation.
The modern school of pre-surgical orthopedic treatment of the cleft lip and palate patient started in the 1950's where series of intraoral plates were used to mold the alveolar segments together. In 1993, nasal bulb attachments were utilized in conjunction with the plate to mold the lip, nose and the alveolus in neonates prior to lip repair.
The method of fabrication of the NAM appliance starts with an initial impression of the infant's palate. The materials commonly used for the impression of the palate are: alginate, polyvinyl siloxane, aluwax, and compound materials. Patients are evaluated for potential airway complications. Stock or customized trays are used to load the impression material. The infant is positioned upright and the tray/impression material is placed in the infant's mouth until the material is set. The tray is removed and the patient's mouth is suctioned and inspected to make sure no material remains in the oral or nasal cavity. The impression is poured up with stone and the plate is fabricated using an acrylic material. The tray is then tried in the patient and lined using a softer denture reline material for better comfort and fit. The nasal stent is fabricated chairside using stainless steel orthodontic wire with a helical design. An acrylic nasal bulb in the shape of a ball is fashioned and the stent is imbedded using acrylic to the fabricated plate. The plate with the nasal stent is inserted and the upper lip is taped using tape to act as a prolabial band. The bulb is positioned inside the nasal passage such that pressure is applied against the alar tissue and the columella causing growth and reducing the cleft. Due to the position of the spring and it being supported from the NAM appliance in the infant's mouth the resulting force applied is primarily medial (toward the centerline of the face) superior (upward) and anterior (away from the face).
The patient is seen in the office or hospital setting on two separate visits for the fabrication of the appliance and the appliance is adjusted every 1-2 weeks until the patient is determined to be ready for primary lip closure surgery. The average time of lip closure in infants can range from 4-6 months.
The custom fabrication of the NAM appliance, doctor time, and weekly appointments for NAM adjustments, make the procedure time consuming, technique sensitive, and expensive. Trained clinicians are also difficult to find. The primary professionals, typically pediatric dentists or orthodontists, who perform pre-surgical infant orthopedics on neonates with cleft lip and palate are usually associated with large hospitals or dental schools and universities. Due to the very time consuming nature of the current NAM fabrication process, potential airway complications, and numerous appointments, there is a need for a more universal appliance that can be adjustable and can be utilized in any medical provider's office or setting with minimal training.
Therefore, it is an object of the present invention to provide an improvement over existing intraoral nasal molding devices/appliances. It is the object of the invention to provide an extraoral device/appliance that can be more easily fitted and adjusted, is more convenient and comfortable, and provides safer and better treatment. It is an object of the present invention to provide an adjustable extraoral appliance that can be fitted to the infant and adjusted without the need for an impression of the maxilla resulting in less risk than NAM devices. There is a need for a device that can be provided to parents with less consumption of doctor time than existing technologies (less office visits)—an easier to size/fit device. There is a need for a less costly and resource consuming device. There is a need for a universal, adjustable, extraoral nasal molding appliance that can be utilized in many rural areas and underserved countries where access to healthcare, and qualified medical and dental professionals are limited. There is also a need for a better performing appliance capable of applying greater forces in the desired directions/vectors.